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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Ventilatory Effort Recorder
510(k) Number K073682
Device Name EMBLETTA GOLD
Applicant
EMBLA SYSTEMS, INC.
11001 W. 120TH AVE.
BROOMFIELD,  CO  80021
Applicant Contact ROBERT G SCHUEPPERT
Correspondent
EMBLA SYSTEMS, INC.
11001 W. 120TH AVE.
BROOMFIELD,  CO  80021
Correspondent Contact ROBERT G SCHUEPPERT
Regulation Number868.2375
Classification Product Code
MNR  
Date Received12/28/2007
Decision Date 08/08/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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